Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal spring, washer, and bearing components may become loose and separate from the device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (foreign object entering the oral cavity) where injury has not yet been reported, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Flexicare Medical Ltd. is recalling specific lots of BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3 laryngoscopes. The recall involves 1,024,890 devices distributed nationwide in the United States and in several international markets, including Australia, Canada, China, and the United Kingdom.
The recall was initiated after the firm received reports that the spring, washer, and bearing components within the laryngoscope blade block can become loose and separate from the device. If the blade is disengaged over a patient's mouth, these loose parts could potentially enter the oral cavity. This hazard may cause a delay in the medical procedure while the loose parts are retrieved.
Healthcare providers and facilities should stop using the affected devices immediately. The specific part number is 040-333U, and the affected lot numbers are 170900328, 180800461, 180900072, 180900104, 181000107, 181100013, 181100097, and 181200024. Users should contact Flexicare Medical Ltd. for instructions on returning or disposing of the recalled products.
The recalled product
- Product
- BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords…
- Manufacturer
- Flexicare Medical Ltd.
- Category
- Medical Device — Laryngoscope
- Affected units
- 1,024,890
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Flexicare Medical Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Flexicare Medical Ltd.
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FDA (Devices) · 2020-12-02
- HighFlexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
FDA (Devices) · 2020-01-22
- HighFlexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
FDA (Devices) · 2020-01-22
- HighFlexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
FDA (Devices) · 2020-01-22
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